Recruiting

Observational Study

Sponsor:

Massachusetts General Hospital

Code:

NCT05577819

Conditions

Transthyretin Amyloidosis

Heart Failure

Heart Failure, Diastolic

Amyloidosis

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Interventions

99mTc-pyrophosphate Scintigraphy

Study Details

Brief summary:

Recent studies have shown that transthyretin amyloidosis (ATTR) can sometimes cause a type of heart failure where the pumping function of the heart is normal, also known as Heart Failure with Preserved Ejection Fraction (HFpEF) or diastolic heart failure. In this single center diagnostic study, we will evaluate for ATTR in patients with HFpEF in order to to determine how frequently this occurs and how we can predict which heart failure patients may have TTR amyloidosis. Our goal is to identify amyloidosis in heart failure patients earlier so that they can start treatment.

Conditions

Transthyretin Amyloidosis

Heart Failure

Heart Failure, Diastolic

Amyloidosis

Study ID

NCT05577819

Start date

Oct 2, 2020

Status verified date

Jul, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Jul 17, 2026

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients with a confirmed diagnosis of HFpEF.
  • Age ≥65 years old

Exclusion Criteria:

  • End stage chronic kidney disease on dialysis (CKD stage 5 as defined as eGFR <15mL/min)
  • no history of HFrEF (LVEF<40%) with the exception of low LVEF in the setting of acute decompensation, AF RVR, ACS/MI, etc
  • Negative 99mTc-pyrophosphate scan within a year
  • Unable to lie down for 15 minutes for the 99mTc-pyrophosphate scan
  • Known diagnosis of amyloidosis
  • Severe valvular heart disease that is uncorrected (moderate to severe is considered exclusionary)

Study Design

Enrollment

515 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Patients 65 and older with Heart Failure with Preserved Ejection Fraction

Patients 65 years and older presenting to Massachusetts General Hospital with a known diagnosis of HFpEF and without a diagnosis of amyloidosis in the ambulatory (outpatient) setting will undergo a 99Tc-Pyrophosphate Scan to identify Cardiac Amyloidosis

Interventions

99mTc-pyrophosphate Scintigraphy

Cardiac Imaging Technique used to diagnose Transthyretin Cardiac Amyloidosis by use of 15 mCi of 99mTC-Pyrophosphate tracer

Primary outcome measure

  • Diagnosis of 99mTc-pyrophosphate scan positive ATTR [ Time Frame: Day 1 (day of study visit) ]

Central Contacts and Locations

Central contacts

Abbie Macher, BS

617-643-6328ajmacher@mgh.harvard.edu

Laura Stockhausen, BS

617-724-1339lstockhausen@mgh.harvard.edu

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Principal Investigator:

Hanna Gaggin, MD

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Sep 1, 2026

Last verified

Jul, 2026

Keywords

  • Transthyretin Amyloidosis
  • Heart Failure
  • Heart Failure, Diastolic
  • Amyloidosis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-11. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2026-09-01. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.